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Hydrogel composition for measuring glucose flux

a technology of glucose flux and composition, which is applied in the direction of therapy, other chemical processes, separation processes, etc., can solve the problems of poor patient compliance, coma and death, and abatement of the monitoring process by the diabetic patien

Active Publication Date: 2006-12-19
ANIMAS TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention relates to the detection of analytes and biologically important molecules in the body. The invention provides compositions for transporting these analytes across membranes using hydrogels and iontophoretic electrodes. The hydrogels can be used in devices that use transdermal extraction or mucosal membrane extraction for the detection and quantification of analytes in a subject. The invention also includes methods of making or manufacturing the hydrogels and collection assemblies / electrode assemblies for use in analyte monitoring devices. The technical effects of the invention include improved detection and monitoring of analytes in the body and improved methods for transporting them across membranes."

Problems solved by technology

On the other hand, improper administration of insulin therapy can result in hypoglycemic episodes, which can cause coma and death.
However, the pain and inconvenience associated with this blood sampling, along with the fear of hypoglycemia, has led to poor patient compliance, despite strong evidence that tight control dramatically reduces long-term diabetic complications.
In fact, these considerations can often lead to an abatement of the monitoring process by the diabetic.

Method used

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  • Hydrogel composition for measuring glucose flux
  • Hydrogel composition for measuring glucose flux
  • Hydrogel composition for measuring glucose flux

Examples

Experimental program
Comparison scheme
Effect test

example 1

Exemplary Hydrogel Formulations

[0219]Table 1 presents the components of three exemplary hydrogel formulations.

[0220]

TABLE 1TotalTotalPEO1 / Bis2 / NaH2PO43 / NaH2PO43 / NaCl4 / H2O / UA5 / PO42− / Cl− / NumberpH(% w / w)(% w / w)(% w / w)(% w / w)(% w / w)(% w / w)(% w / w)(mM)(mM)A7.410.010.262.170.984.930.2100150B7.410.010.524.340.982.540.2200150C7.410.010.786.540.980.110.23001501PEO: polyethylene oxide, Mr 600,000.2Bis: bisacrylamide is % w / w of a 2% stock methylene bis acrylamide solution.3In some formulations, particular where the total PO42− concentration is greater than about 200 mM, it is preferable (for some applications) to use potassium phosphate salts.4The Cl− ion concentration is typically 0.9% regardless of the chloride salt used. For example, in some formulations, particular where the total PO42− concentration is greater than about 200 mM, it is preferable (for some applications) to use KCl as the Cl− ion source.5UA: Undecylenic acid as sodium salt.

[0221]Nominal (Standard) Glucose oxidase enzyme (GO...

example 2

Analyte Flux

A. Buffer Systems

[0225]Analyte flux was measured across skin surface using the exemplary analyte glucose. Glucose flux across skin surface was determined as a function of buffer composition. Buffer systems had varying concentrations of phosphate buffer (formulated from sodium salts of monobasic and dibasic phosphate) and pH. The electrolyte concentration was the same for all buffers (0.9% NaCl). In general, two Ag / AgCl electrode, liquid reservoir systems (i.e., two collection reservoir chambers) were placed on each arm of a subject. The current was provided using Iomed Phoresors (Iomed, Salt Lake City, Utah) using an alternating polarity scheme. Briefly, the current was applied for 7.5 minutes for current flow in a first direction, then the polarity was switched so current flowed in the reverse direction, i.e., a second direction, for 7.5 minutes. Thus, each reservoir received the same amount of anodal and cathodal iontophoresis in the 15 period. Current was 0.7 mA=0.25 ...

example 3

Clinical Studies and Results Concerning Performance of the High Phosphate Gels of the Present Invention

[0268]The high phosphate hydrogels of the present invention were used in clinical trials to confirm the efficacy and benefits of the high phosphate hydrogels of the present invention. The tested conditions included the following:[0269]Condition 1: Control (Standard Sensor ink, Standard Hydrogel—100 mM sodium phosphate and Delnet scrim.[0270]Condition 2: Alternative Sensor ink, Standard Hydrogel—100 mM sodium phosphate and Delnet scrim.[0271]Condition 3: Standard Sensor ink, High Phosphate Hydrogel—200 mM potassium phosphate with Delnet scrim.[0272]Condition 4: Alternative Sensor ink, High Phosphate Hydrogel—200 mM potassium phosphate with Delnet scrim.

[0273]The clinical trial population consisted of 66 subjects: age 18 years and older (Mean age=45.1); and, 41 females and 25 males with type 1 or type 2 diabetes mellitus (55 Type 1, 11 Type 2). GlucoWatch G2 biographers, providing ea...

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Abstract

The present invention relates to compositions for use in analyte monitoring devices. These compositions are useful to increase the flux of analyte across skin, tissue or mucosal surfaces. The compositions include hydrogels and collection reservoir systems comprising ionically conductive materials. The present invention also includes methods of making / manufacturing hydrogels or collection reservoir systems, collection assemblies comprising the hydrogels, electrode assemblies in combination with the hydrogels or collection reservoir systems, and methods of using the same.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 404,807, filed 19 Aug. 2002, which application is herein incorporated by reference in its entirety.TECHNICAL FIELD[0002]The present invention relates generally to compositions and methods for the enhancement of transdermal analyte flux.BACKGROUND OF THE INVENTION[0003]A number of diagnostic tests are routinely performed on humans to evaluate the amount or existence of substances present in blood or other body fluids. These diagnostic tests typically rely on physiological fluid samples removed from a subject, either using a syringe or by pricking the skin. One particular diagnostic test entails self-monitoring of blood glucose levels by people with diabetes.[0004]Diabetes is a major health concern, and treatment of the more severe form of the condition, Type 1 (insulin-dependent) diabetes, requires one or more insulin injections per day. Insulin controls utiliz...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): C12Q1/54A61B5/00A61N1/30A61N1/32C08J3/075
CPCA61B5/1486A61N1/044A61N1/325C08J3/075A61N1/0436
Inventor TAMADA, JANET A.TIERNEY, MICHAEL J.WILLIAMS, STEPHEN C.
Owner ANIMAS TECH
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